Dossier DOS-016
Dossier in NeeS format, version 5.1.3, for application TITCK-2024-0016. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-016
Format
NeeS
Version
5.1.3
Status
Overdue
Application
Created
2022-05-13
Updated
2023-08-08
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 7 | Approved |
| 2 | CTD Summaries | 10 | Completed |
| 3 | Quality | 5 | Failed |
| 4 | Nonclinical Study Reports | 7 | Approved |
| 5 | Clinical Study Reports | 3 | Completed |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-016 | 1.8.3 | Cover Letter | 9.6 | XML | 610 | Submitted | Carlos Mendez |
| CC-116 | 1.1.6 | Cover Letter | 8.3 | Word | 4,836 | Overdue | Dmitri Volkov |
| CC-216 | 1.4.6 | Patient Labeling | 8.6 | Word | 12,700 | Pending | Marcus Webb |
| CC-316 | 1.9.6 | Prescribing Information | 9.9 | XML | 10,860 | In Progress | James O'Brien |
| CC-416 | 4.9.9 | Toxicology Studies | 3.3 | XML | 9,729 | Failed | James O'Brien |
| CC-516 | 1.1.9 | Cover Letter | 3.1 | XML | 9,988 | Active | Tomoko Ikeda |
| CC-616 | 2.5.3 | Quality Overall Summary | 9.6 | HTML | 7,440 | Draft | Priya Sharma |
| CC-716 | 1.7.8 | Cover Letter | 1.3 | 14,352 | Active | Dmitri Volkov | |
| CC-816 | 4.9.2 | Pharmacology Studies | 7.6 | 2,051 | Active | Sarah Chen | |
| CC-916 | 5.6.5 | Study Reports – Clinical Pharmacology | 2.8 | XML | 4,740 | Overdue | Carlos Mendez |
| CC-1016 | 5.3.8 | Study Reports – Efficacy | 11.5 | 12,607 | Completed | Nadia Petrova | |
| CC-1116 | 1.1.3 | Proposed Conditions of Approval | 4.8 | 11,301 | Draft | James O'Brien | |
| CC-1216 | 4.8.3 | Genotoxicity | 6.2 | HTML | 3,031 | Approved | James O'Brien |
| CC-1316 | 3.4.7 | Manufacturing Process | 3.0 | Word | 12,393 | Approved | Aisha Okonkwo |
| CC-1416 | 3.8.1 | Drug Product | 1.8 | Word | 8,631 | Pending | Marcus Webb |
| CC-1516 | 5.1.3 | Integrated Summary of Efficacy | 1.4 | 1,321 | Approved | Lieselotte van der Berg | |
| CC-1616 | 3.3.8 | Drug Product | 2.3 | 10,453 | Pending | Priya Sharma | |
| CC-1716 | 5.4.9 | Study Reports – Efficacy | 10.5 | HTML | 7,081 | Approved | Carlos Mendez |
| CC-1816 | 5.5.1 | Integrated Summary of Safety | 4.8 | 4,032 | Submitted | Nadia Petrova | |
| CC-1916 | 4.7.2 | Pharmacology Studies | 3.2 | Word | 14,190 | Submitted | Lieselotte van der Berg |
Showing 20 of 20 components